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European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent

NCT00637104 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2010-02-09

No results posted yet for this study

Summary

The main objective of this study is to assess the safety and effectiveness of the TiN-coated MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to an uncoated control cobalt-chromium balloon-expandable stent (Vision, Abbott Vascular). Both stents are mounted on a Rapid Exchange Stent Delivery System.

Conditions

Interventions

DEVICE

Mar-Tyn TiN coated Co-Cr Numen stent implant

Implant of the Mar-tyn TiN coated stent

DEVICE

Vision Co-Cr stent implant

Implant of the Vision stent

Sponsors & Collaborators

  • International Biomedical Systems S.p.A.

    lead INDUSTRY

Principal Investigators

  • Marco Balducelli, MD,FESC,FACC · Ospedale "S.Maria delle Croci" - Ravenna, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • Germany
  • Italy
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637104 on ClinicalTrials.gov